CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 45 enrolled
Drug / intervention
Transplantation of circulating CD14+CD34+cells +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02454231
NCT02454231Phase 3Completed
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Monocentric Randomized Study for the Therapy of Critic Limb Ischemia With Bone Marrow- or Peripheral Blood-derived Stem Cells

University of Florence·interventional·Posted May 27, 2015·Updated May 9, 2017

In Brief

A Phase 3 clinical trial evaluating Transplantation of circulating CD14+CD34+cells and Transplantation of BM MNC for Critical Limb Ischemia. Completed, enrolled 45 participants across 1 site.

Detailed Summary

The investigators designed a randomized clinical trial (stem cell emergency life threatening arteriopathy or SCELTA) to compare the therapeutic efficacy of the auto-transplant of enriched circulating EPCs (ECEPCs) with auto-transplant of BM-MNCs. ECEPCs, obtained by immunoselection of CD14+ and CD34+ cells, or BM-MNCs, were injected intramuscularly in the affected limb of patients with critical limb ischemia (CLI).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCritical Limb Ischemia
CountriesItaly
CollaboratorsTuscany Region

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 27, 2015
Enrollment StartSep 1, 2009
Primary CompletionMay 1, 2015
Study CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 11.1 years ago

Interventions

Transplantation of circulating CD14+CD34+cellsbiological

intramuscular injection of circulating EPC at leg level

Transplantation of BM MNCbiological

intramuscular injection of BM MNC at leg level